MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 BARD SOFT MESH; SURGICAL MESH

Catalog Number	0117011
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994)
Date of Event	06/17/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: on (b)(6) 2013: patient was diagnosed with recurrent paraesophageal hernia and recurrent suprapubic ventral hernia thereby underwent laparoscopic repair with implant of bard soft mesh (device 1) and synthetic mesh.Per op notes, ¿adhesions of stomach were taken down.The paraesophageal hernia sac was noted and repaired using synthetic mesh.The suprapubic ventral hernia sac with incarcerated peritoneal fat was reduced.A bard soft mesh (device 1) was placed and sutured.¿ on (b)(6) 2015: patient was diagnosed with lower abdomen pain, bilateral inguinal hernia and umbilical hernia thereby underwent laparoscopic repair with partial excision of bard soft mesh (device 1) and implant of 3dmax (device 2 and 3).Per op notes, ¿adhesions were lysed.The prior mesh (device 1) was noted and dissected free in 3 to 4 pieces and removed.The bilateral inguinal hernia sacs were noted and transected.Two 3dmax meshes (device 2 - left and 3 ¿ right) were placed and sutured.The umbilical hernia defect was noted and repaired with sutures.¿ on (b)(6) 2015: patient was diagnosed with ventral hernia thereby underwent robotic repair with implant of synthetic mesh.(note: the prior mesh was not visualized during this procedure).
Additional Manufacturer Narrative
Root cause is inconclusive; no conclusion can be made as to the extent to which the implant may have caused or contributed to the patient's postoperative course.Note, the manufacturing date (15-feb-2013) is considered to be a best estimate.This emdr was submitted to represent the bard soft mesh (device #1).Additional supplemental emdr submitted to represent the 3dmax (device #2).Note: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• Brand Name: BARD SOFT MESH
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 23083328
• Report Number: 1213643-2025-00868
• Device Sequence Number: 4748651
• Product Code: FTL
• UDI-Device Identifier: 00801741030888
• UDI-Public: (01)00801741030888(17)180228(10)HUXB0157
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K052155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/16/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2018
• Device Catalogue Number: 0117011
• Device Lot Number: HUXB0157
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2025
• Initial Report FDA Received Date: 09/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/15/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female